The DML instrument is intended to be used only in combination with QIAGEN Kits indicated for use with the DML instrument for applications described in the respective QIAGEN Kit handbooks.

Performance

The DML instrument is a benchtop, computer-controlled instrument designed for measuring and analyzing light produced by the glow-type chemiluminescence used in HC2 technology. The DML instrument measures light in the visible spectrum (300–650 nm) and measures chemiluninescence from opaque microplates.

Peformance specifications of the DML 2000

Performance measure

Specification

Spectral sensitivity range

300–650 nm

Dynamic range

10 to 5 x 106 RLU

Cross-talk (measured from adjacent well)

Less than 3.0 x 10–5 RLU

Principle

Hybrid Capture 2 technology detects RNA–DNA hybrids using signal-amplified chemiluminescent techology. HC2 technology delivers the accuracy and flexibility necessary for routine detection of DNA that can assist in the diagnosis of infectious diseases. The DML instruments automate the signal detection and results reporting for HC2 assays.

Procedure

Once a microplate has been processed manually or using the Rapid Capture System (RCS), the microplate is loaded at the front of the DML instrument. The individual microplate wells are sequentially moved beneath the opening of the detector and individually measured. The digene HC2 System Software provides data reduction and works in conjunction with the DML instrument to report final results. The software interface between the digene HC2 System Software and the Laboratory Information System (LIS) can be programmed to transmit data into reportable results by a testing laboratory.

Applications

A range of digene HC2 DNA Tests enable the detection of pathogens using the DML instrument as part of the high-throughput workflow with the Rapid Capture system or as part of the manual workflow of the Hybrid Capture 2 Modular System. The combination of HC2 kits and a DML instrument may be used for testing the following pathogens:

High-risk human papillomavirus (HPV) infections

Chlamydia trachomatis (CT) infections

Neisseria gonorrhoeae (GC) infections

Software

The DML 2000 uses the digene HC2 System Software. Refer to the DML instrument user manual along with the other user manuals provided as part of the digene HC2 System Suite 4.1.